OrganOx
DevOps Engineer/Senior
OrganOxUnited Kingdom23 hours ago
Full-timeRemote FriendlyEngineering
ABOUT ORGANOX:

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Position Summary

The DevOps Engineer/Senior is responsible for the design, implementation and management of the ISO 62304 compliant CI/CD pipeline for the software development at OrganOx.

The DevOps Engineer/Senior will be actively involved in the entire Software Development Life Cycle (SDLC), focusing on automation of standardised development activities (e.g. static analysis, SBOM creation, vulnerability tests), management of version control system, including branching strategies and release process, as well as owning the software toolchain configuration, upkeep and continuous improvement.

The DevOps Engineer/Senior will collaborate closely with cross-functional teams, including Digital, Data Science/ML Engineers, Systems Engineers, QARA team, Operations and Field Service teams, to support the development of software for medical devices, whilst also supporting Design Transfer and software releases. These activities encompass Product Engineering, New Product Development and Innovation initiatives, carried out in collaboration with both internal teams and external stakeholders.

This is an on-site role in Oxford with flexibility, to ensure the creation and release of world-class software for OrganOx.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

Major Responsibilities

Under direction from the Director of Embedded Software Development, the DevOps Engineer will be responsible for:

CI/CD automation:

  • Design, implement, and maintain CI/CD pipelines for build, test, and deployment ensuring compliance with industry standards such as IEC 62304, IEC 13485 and FDA regulations, critically including cybersecurity requirements
  • Automating build, packaging and release processes to produce repeatable and traceable artefacts
  • Integration of automated testing (unit, integration, system) into pipelines
  • Managing environment promotion, approval gates and release controls


Source Control and Build Management:

  • Enforcing branching strategies, pull requests and peer review
  • Build orchestration and dependency management
  • Creating reproducible builds and artefact versioning
  • Managing build agents and runners


Infrastructure and Platform Engineering:

  • Provisioning and maintaining cloud, onprem or hybrid environments
  • Containerisation and orchestration (e.g. Docker, Kubernetes)
  • Managing runtime environments for development, test, and production
  • Monitoring infrastructure health, performance, and availability
  • Proactively seek out opportunities to improve infrastructure reliability availability, and recovery with root cause analysis, failure investigations, by implementing defect remediation and new functionalities
  • Supporting incident response, root cause analysis, and remediation
  • Performance monitoring and capacity planning


Quality, Compliance & Traceability (where applicable)

  • Supporting traceability from requirements to code, build, and deployment
  • Ensuring build and release processes are auditable and reproducible
  • Tool qualification and controlled change management in regulated environments
  • Supporting evidence generation for audits and review


Process Improvement:

  • Actively contribute to Lean/Agile initiatives, including but not limited to optimisation of QMS (Quality Management System) processes.
  • Remain current and up to date with development in the software engineering domain


Collaboration & Troubleshooting:

  • Work in close partnership with cross-functional teams, to diagnose and resolve issues efficiently
  • Enable developer productivity through self-service tooling
  • Support Agile and iterative delivery models
  • Create clear documentation of pipelines, infrastructure and operational processes
  • Coach teams on DevOps best practices
  • Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies


Requirements


Skills & Experience

  • Focused and proven experience creating, implementing, documenting, maintaining and evolving both CI/CD pipelines, as well as test systems for complex, safety-critical software across embedded and cloud connected devices
  • Focused and proven experience creating, implementing, documenting, evolving and enforcing both CI/CD pipelines and test systems for complex, safety-critical software across embedded and cloud-connected devices
  • Proven experience designing, building and maintaining DevOps infrastructure
  • Demonstrated ability to evaluate, select, and onboard new technologies and tooling, including producing associated qualification and risk documentation required in a regulated environment.
  • Comfortable driving the design and implementation of the DevOps environment, bringing structure and best practice
  • Comprehensive technical knowledge of pipeline standards and software process automation, with strong focus on risk management, cybersecurity, scalability, maintainability and reliability.
  • Proven track record of managing external technical partners, ensuring the quality of deliverables across all aspects of design control, within regulated industries
  • Demonstrable proactivity in identifying technical risks and implementing effective mitigation strategies.
  • Experienced in developing innovative solutions and maintaining existing products while ensuring adherence to internal QMS and relevant industry standards
  • Demonstrated track record of supporting process improvements to enhance efficiency and compliance.
  • Cost awareness and optimisation of DevOps platforms
  • Proven track record delivering high-quality software process automation solutions in regulated industries; Medical Device development under IEC 62304 preferred; Aerospace or Automotive are also acceptable
  • Understanding of software tool qualification obligations and design control (traceability, DHF/DHR tools)
  • Demonstrated security-conscious approach to infrastructure and permissions management applying least-privilege principles, avoiding broad or persistent access grants and treating secrets and credentials with appropriate rigour
  • Highly effective in applying problem-solving techniques (e.g. brainstorming, 5-whys, fishbone), supported by demonstrable structured and rigorous approach to define activities and achieve tangible deliverables with limited supervision
  • An effective communicator, who readily engages in a timely and proactive manner
  • Proven ability to collaborate in cross-functional teams
  • Demonstrates appropriate & considered diligence when handling sensitive access to production systems, regulatory artefacts, and device infrastructure


Technical Expertise:

  • Pipeline-as-code, using YAML or equivalent
  • Strong experience with distributed version control systems (e.g. Git); branching strategies and protected branch policies
  • Experience with major cloud platforms (Azure preferred, AWS/GCP acceptable)
  • Identity and access management (IAM), secrets, and key management
  • Deep appreciation of agile methodologies, best practices, and proactive contribution to project planning
  • Proven ability to produce DHF-compliant documentation to a high standard, aligned with QMS (Quality Management System) requirements
  • Strong focus on traceability, repeatability, and compliance without compromising engineering quality
  • Scripting languages: PowerShell, Python, Bash (for build automation, device provisioning, and deployment workflows)
  • Sufficient .NET and C/C++ knowledge to debug and diagnose build pipeline failures across managed and native codebases
  • Familiarity with embedded toolchains and cross-compilation environments
  • Infrastructure-as-code (e.g. Terraform, Pulumi, Bicep).


Development Approach:

  • A deep appreciation of agile methodologies, their implementation and best practices in software development.
  • Proactive participation and contribution to project planning activities in the Agile context.
  • Proven ability to produce documentation for the DHF (Design History File) with high quality standard and compliant with QMS requirements and related standards.
  • Strong demonstrable experience of managing internal and external stakeholders from initial engagement (i.e. design input) throughout the design and development phases, to acceptance of deliverables.
  • Strong focus on traceability, repeatability and compliance, without sacrificing or compromising on engineering quality


Qualifications

  • Degree in Computer Science or relevant engineering discipline


Tools & Practices: Proven ability and expertise in -

  • CI/CD: Azure DevOps (preferred)
  • Version control: Git, Bitbucket, SVN
  • Test frameworks: xUnit, NUnit, MSTest, VectorCAST
  • Requirements management: Codebeamer, Jama, Polarion
  • Work item management: Jira, Azure Boards
  • Static analysis and SBOM generation in a regulated context advantageous


Benefits

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.

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